Neo chordae tendinae deployment system

ABSTRACT

Methods and devices for transvascular prosthetic chordae tendinea implantation are disclosed. A catheter is advanced into the left atrium. A helical ventricular anchor subassembly is advanceable through the catheter, having a ventricular suture extending proximally through the catheter. A leaflet anchor subassembly is advanceable through the catheter, having a leaflet suture extending proximally through the catheter. From an atrium side, the leaflet anchor subassembly can be anchored to a superior surface of a mitral valve leaflet and a leaflet anchor can be advanced into the mitral valve leaflet to secure the mitral valve leaflet to the leaflet suture. The ventricular anchor subassembly secures the ventricular anchor to a ventricular wall. The leaflet suture and the ventricle suture may be tensioned and connected by a suture lock to form an artificial chordae.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/297,422, filed Mar. 8, 2019, which claims the benefit under 35 U.S.C.§ 119(e) of U.S. Provisional Application No. 62/641,612 filed Mar. 12,2018, the entirety of which is hereby incorporated by reference hereinfor all purposes. U.S. application Ser. No. 16/297,422 also is acontinuation-in-part of U.S. application Ser. No. 15/858,671, filed Dec.29, 2017, which is a continuation-in-part of U.S. application Ser. No.15/638,176, filed Jun. 29, 2017, now U.S. Pat. No. 9,877,833, whichclaims priority to U.S. Provisional Application 62/441,031, filed onDec. 30, 2016, the entirety of each of these applications is herebyincorporated by reference herein for all purposes. Any and allapplications for which a foreign or domestic priority claim isidentified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

BACKGROUND

The present disclosure relates to mitral valve repair or replacement andmore generally to methods and methods and devices for mitral valvereshaping, repair and/or replacement of mitral chords to restore properfunctioning of the mitral valve from a state of mitral valveregurgitation.

DESCRIPTION OF THE RELATED ART

The heart includes four heart valves, which allow blood to pass throughthe four chambers of the heart in one direction. The four valves are thetricuspid, mitral, pulmonary and aortic valves. The four chambers arethe right and left atria (upper chambers) and right and left ventricle(lower chambers).

The mitral valve is formed by two leaflets, which are known as theanterior leaflet and the posterior leaflet, which open and close inresponse to pressure placed on the leaflets by the pumping of the heart.There are several problems that can develop or occur with respect to themitral valve. Such problems include mitral valve regurgitation (MR), inwhich the mitral valve leaflets do not close properly, which can causeleakage of the mitral valve. Severe mitral regurgitation can adverselyaffect cardiac function and compromise a patient's quality of life andlife-span.

Several techniques have been developed, for correcting mitral valveregurgitation. These include heart transplant, valve replacement orrepair, chordae tendinea shortening or replacement and mitral annularrepair also known as annuloplasty, depending upon the stage andunderlying etiology.

As it relates to chordae tendinea replacement or repair, certainsurgical and trans apical approaches have been proposed. Despite thoseefforts, however, there remains a need for a transvascular approach forchordae tendinea replacement or repair, to reduce or eliminate MR.

SUMMARY

An aspect of the invention includes a method of transvascular prostheticchordae tendinae implantation, comprising the steps of: advancing acatheter into the left atrium, through the mitral valve, and into theleft ventricle; deploying a ventricular anchor from the catheter andinto a wall of the left ventricle, leaving a ventricular suture attachedto the ventricular anchor and extending proximally through the catheter;from an atrium side, advancing a leaflet anchor through a superiorsurface of a mitral valve leaflet to position a leaflet anchor againstthe inferior (ventricular) side of the leaflet with a leaflet sutureextending proximally through the leaflet, into and through the catheter;and securing the leaflet suture over the top of the leaflet coaptiveedge to the ventricular suture to limit a range of travel of the leafletin the direction of the left atrium.

Another aspect of the disclosure is a leaflet anchor deployment system,comprising: a catheter having a proximal end and a distal end; a leafletanchor positioned on a distal end of the catheter; and a needleadvanceable through the leaflet anchor, the needle releasably carrying aradially enlargeable leaflet anchor preloaded therein and having asuture extending proximally through the catheter.

In accordance with another aspect of the invention there is provided amethod of transvascular prosthetic chordae tendinae implantation. Themethod comprises the steps of advancing a catheter into the left atrium,through the mitral valve, and into the left ventricle; deploying aventricular anchor from the catheter and into a wall of the leftventricle, leaving a ventricular suture attached to the ventricularanchor and extending proximally through the catheter; from an atriumside, securing a leaflet anchor catheter to a mitral valve leaflet; withthe leaflet anchor catheter secured to the leaflet, advancing a leafletanchor from the catheter through the mitral valve leaflet to secure themitral valve leaflet to a leaflet suture, with the leaflet sutureextending proximally through the catheter; and securing the leafletsuture to the ventricular suture to limit a range of travel of theleaflet in the direction of the left atrium.

The step of advancing a leaflet anchor from the catheter through themitral valve leaflet to secure the mitral valve leaflet to a leafletsuture may comprise advancing a needle preloaded with the leaflet anchorthrough the superior surface of the mitral valve leaflet. The securing aleaflet anchor catheter to a mitral valve leaflet step may compriseusing a leaflet connector. The leaflet connector may comprise a helicalanchor or a tissue hook.

In accordance with another aspect of the invention there is provided amethod of securing a leaflet anchor to a mitral valve leaflet. Themethod comprises the steps of advancing a catheter into the left atrium;from an atrium side, securing a leaflet connector coupled to thecatheter to a mitral valve leaflet from an atrial side of the leaflet;and after securing the leaflet connector to the mitral valve leaflet,advancing a leaflet anchor through the mitral valve leaflet to securethe mitral valve leaflet to a leaflet suture.

The step of advancing a leaflet anchor through the mitral valve leafletto secure the mitral valve leaflet to a leaflet suture may compriseadvancing a needle preloaded with the leaflet anchor through the mitralvalve leaflet from the atrial side. The needle may be advanced throughthe leaflet connector. The leaflet connector may comprise a helicalanchor.

In accordance with another aspect of the invention there is provided aleaflet anchor deployment system. The system comprises a catheter havinga proximal end and a distal end; a leaflet connector positioned on adistal end of the catheter; and a needle advanceable through the leafletconnector, the needle including a radially enlargeable leaflet anchorpreloaded therein and having a suture extending proximally through thecatheter. The leaflet connector may comprise a helical anchor.

In accordance with another aspect of the invention there is provided aneo chordae tendinae deployment system. The system comprises a catheterhaving a proximal end and a distal end; a helical ventricular anchorsubassembly extendable through the catheter, having a ventricular sutureextending proximally through the catheter; and a leaflet anchordeployment subassembly extendable through the catheter, having aradially enlargeable leaflet anchor within the subassembly and having aleaflet suture extending proximally through the catheter.

The radially enlargeable leaflet anchor may comprise a pledget. Thepledget may be transformable from an elongate strip configuration to aradially enlarged, axially shortened configuration by proximalretraction of the suture. The radially enlargeable leaflet anchor maycomprise the leaflet suture positioned between two sheets of material.The radially enlargeable leaflet anchor may be carried within a needlehaving a sharpened end for piercing the leaflet. The leaflet anchordeployment subassembly may comprise an elongate tube having a distal endand a central lumen, and a leaflet connector on the distal end. Theleaflet connector may comprise a helical leaflet anchor. The needle maybe axially movable with respect to the helical leaflet anchor. Thesystem may further comprise a suture locking subassembly, advanceablethrough the catheter and configured to connect the ventricular suture tothe leaflet suture.

In accordance with another aspect of the invention there is provided aleaflet anchor delivery subsystem. The subsystem comprises an elongateflexible tubular body, having a proximal end, a distal end and a centrallumen; a deployment needle axially movably advancable through thecentral lumen; a leaflet anchor carried within the deployment needle;and a leaflet connector carried by the distal end of the tubular body.The leaflet anchor may comprise a helical element. The deployment needlemay be axially extendable through the helical element.

In accordance with another aspect of the invention there is provided atissue anchor. The tissue anchor comprises a hub; a suture extendingproximally from the hub; a helical anchor extending distally from thehub; a core wire extending concentrically through the helical anchor,and beyond the distal end of the helical anchor.

The tissue anchor may further comprise a suture anchor guide extendingproximally from the hub. The tissue anchor may further comprise atubular sleeve having a length of no more than about 10 cm extendingproximally from the hub. The tissue anchor may further comprise aradiopaque marker carried by the sleeve. The tissue anchor may furthercomprise a radiopaque marker axially movably carried by the core wire.The tissue anchor may further comprise a spring carried by the corewire. The tissue anchor may further comprise a tissue piercing point ona distal end of the helical anchor, and a barb on the helical anchorconfigured to resist rotation of the helical anchor out of engagementwith tissue.

In accordance with another aspect of the invention there is provided atissue anchor with dynamic depth indicator. The tissue anchor comprisesa hub; a tissue anchor extending distally from the hub; a core wireextending distally from the hub; a radiopaque marker movably carried bythe hub; and a spring for biasing the radiopaque marker in a distaldirection; wherein the radiopaque marker is advanced proximally withrespect to the tissue anchor in response to the tissue anchor advancinginto tissue.

In accordance with another aspect of the invention there is provided anendovascular suture lock. The suture lock comprises a body having asuture path extending therethrough; a movable wall in the housing, forreducing a cross sectional dimension of the suture path; a rotatablecoupling on the housing; and a drive mechanism for advancing the movablewall in response to rotation of the coupling.

The suture lock may additionally comprise a friction enhancing surfaceexposed to the suture path. The friction enhancing surface may be on themovable wall. The suture lock may comprise a push wedge having an angledsurface and axially movable within the housing. Rotation of the couplingmay advance the push wedge axially which advances the movable walllaterally to change the cross sectional dimension of the suture path.The movable wall may comprise a suture gripping surface on a first sideand a ramp surface on a second side, the ramp surface configured forsliding contact with the angled surface on the push wedge.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features of the present disclosure will becomemore fully apparent from the following description and appended claims,taken in conjunction with the accompanying drawings. Understanding thatthese drawings depict only several embodiments in accordance with thedisclosure and are not to be considered limiting on scope.

FIG. 1 illustrates placement of a ventricular anchor via transceptalapproach to the mitral valve.

FIGS. 2A and 2B illustrate a ventricular anchor.

FIG. 2C is a perspective view of a ventricular anchor on the distal endof a ventricular anchor deployment tool.

FIG. 2D is a perspective view of the proximal end of a ventricularanchor deployment tool.

FIG. 2E is a partially exploded perspective view of a ventricular anchorand the distal end of a ventricular anchor deployment tool.

FIG. 3 illustrates the deployment end of a catheter positioned to engagea leaflet of the mitral valve.

FIG. 4 illustrates the leaflet captured by the helical leaflet anchor,and a needle crossing through the leaflet from the atrium to theventricle.

FIG. 5 illustrates a pledget type leaflet anchor deployed from theneedle and into the ventricle.

FIG. 6A illustrates proximal traction on a leaflet suture to collapsethe pledget against the ventricular side of the leaflet.

FIGS. 6B-6D illustrate details of a pledget type leaflet anchor.

FIG. 7 illustrates a deployed leaflet anchor and suture and a deployedventricular anchor and suture ready for tensioning and attachment of asuture lock.

FIG. 8 illustrates a perspective view of a distal end of the leafletanchor delivery subsystem.

FIG. 9 illustrates a perspective view of a proximal end of the leafletanchor delivery subsystem.

FIG. 10 illustrates an exploded view of the distal end of the leafletanchor delivery subsystem.

FIG. 11 depicts advancing a suture lock via a suture lock deliverysubsystem over the leaflet anchor suture and ventricular anchor sutureto connect the leaflet anchor to the ventricular anchor.

FIG. 12 depicts the suture lock in a locked position after the tensionhas been adjusted and the suture tails having been severed.

FIG. 13 depicts a perspective view of a distal end of the suture lockdelivery subsystem.

FIG. 14 depicts a perspective view of a proximal end of the suture lockdelivery subsystem.

FIG. 15 depicts a partially exploded view of the distal end of thesuture lock delivery subsystem.

FIG. 16 depicts a perspective view of a distal end of a suture cuttingassembly.

FIG. 17 depicts a side view of a cutting assembly portion of the suturelock delivery subsystem in a configuration where the cutting head is notyet advanced for holding the sutures prior to being severed.

FIG. 18 depicts a side view of the cutting assembly portion of thesuture lock delivery subsystem in a configuration where the cutting headhas been advanced for severing the sutures.

FIG. 19 depicts a side view of a suture lock and a distal end of atorque driver configured to engage the suture lock.

FIG. 20 depicts a proximal end view of a suture lock.

FIG. 21 depicts a distal end of view of a suture lock.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

U.S. patent application Ser. No. 15/858,671, filed Dec. 29, 2017 (theentirety of which is hereby incorporated by reference herein disclosessystems and methods for the transvascular prosthetic chordae tendinaeimplantation. One aspect involves advancing a catheter into the leftatrium, through the mitral valve, and into the left ventricle; deployinga ventricular anchor from the catheter and into a wall of the leftventricle, leaving a ventricular suture attached to the ventricularanchor and extending proximally through the catheter; and advancing aleaflet anchor into a mitral valve leaflet to secure the mitral valveleaflet to a leaflet suture, with the leaflet suture extendingproximally through the catheter, and extending the leaflet suture overthe top of the coaptive edge and securing the leaflet suture to theventricular suture to limit a range of travel of the leaflet in thedirection of the left atrium. Certain aspects are developed furtherherein.

The approach to the mitral valve can be accomplished through a standardtransceptal approach to provide access to the left atrium. With thisaccess, a first step can include securing a leaflet capture catheter tothe leaflet of the mitral valve in the location determined to bestcorrect regurgitation. Probing the surface of the leaflet from thesuperior atrium surface can advantageously provide immediate feedback asto the optimal location to add an additional mitral valve chord. Inanother implementation of the invention, the ventricular anchor isdeployed first, followed by deployment of the leaflet anchor.

Referring to FIG. 1, a ventricular anchor such as a helical anchor 32has been deployed near the apex 20 of the left ventricle 24. While thehelical anchor 32 is shown positioned near the apex 20 in the followingFigures, the anchor 32 can be attached at a point that is offset fromthe thin tissue of the apex, and can be instead implanted in thegenerally thicker adjacent wall of the ventricle, such as between thetwo papillary muscles. This allows the implanted neo chord construct(suture, optional neo papillary muscle, and/or the helical anchor) to bealigned along a longitudinal axis substantially parallel to orconcentric with the original path of the native chord. In certainembodiments, the implanted neo chord construct is aligned along alongitudinal axis that is within 5 degrees, 10 degrees, or 15 degrees ofbeing parallel with the original path of the native chord and/or thepath of the adjacent native chord. In addition, while a helical anchoris illustrated the anchor can have a different structure for engagingtissue of the heart and thus other tissue anchor structures can be usedinstead of a helical structure including various piercing, hook orradially expandable structures known for engaging tissue.

Referring to FIGS. 2A and 2B, there is illustrated one implementation ofa tissue anchor suitable for use as a ventricular anchor in accordancewith the present invention. The anchor assembly 50 will be describedprimarily in the context of the present chordae repair application,however the anchor may be utilized in any of a wide variety of otherapplications where a soft tissue or bone anchor may be desired.

The anchor assembly 50 generally comprises a coil 54 which may compriseany of a variety of materials such as stainless steel or Nitinol. Thecoil 54 extends helically between a proximal end 56 and a distal end 58.Distal end 58 is provided with a sharpened tip 59, and also carries aretention barb 61, configured to resist reverse rotation of the coil anddetachment from tissue. The proximal end 56 of the coil 54 is carried by(attached to or formed integrally with) a hub 57 discussed in additionaldetail below.

Extending distally from the hub 57 and within the coil 54 is an elongatecore wire 62 having a sharp, tissue piercing distal end 64. The distalend 64 is positioned distally of the distal end 58 of the coil 54. Thisenables the sharp distal end 64 to pierce tissue upon contact, and priorto beginning rotation of the coil 54 to embed the coil 54 within thetarget tissue. Engaging the tip 64 prior to rotation of the anchorstabilizes the anchor against sideways movement allowing a singleplacement of the anchor 50 against tissue, and rotation of the coil 54to engage tissue, without ‘walking’ of the anchor away from the desiredtarget site as will be understood by those of skill in the art. Aproximal end of the core wire 62 may be attached to the hub in any of avariety of ways, such as by soldering, brazing, adhesives and/ormechanical interference such as by entering an aperture in a sidewall orother surface of the hub 57.

A radiopaque depth marker 66 is provided with an aperture 68 and isaxially movably carried on the core wire 62. A distal stop 70 such as aradially outwardly extending protrusion or annular ridge is carried bythe core wire 62, and spaced proximally of the sharpened distal end 64to provide a core wire leading segment 72 on the distal side of the stop70 so that the marker 66 cannot interfere with the tissue anchoringfunction of the distal tip 64. The stop 70 functions to limit distaltravel of the marker 66. The marker 66 may be an annular structure suchas a circular disc with a central aperture to receive the core wire 62.

A coil spring 71 is concentrically carried over the core wire 62 andbiases the radiopaque marker 66 in the distal direction. The radiopaquemarker 66 is thus held in position against a proximal surface of thestop 70. In use, the marker 66 rides on the surface of tissue at thetarget attachment site. As the helical coil anchor 54 is rotated andadvances distally into tissue, the marker 66 rides proximally on thecore wire 62 along with the tissue surface, compressing the coil spring71 until the marker 66 is retracted proximally to the hub when thetissue anchor is fully embedded. This enables fluoroscopic visualizationof the progress of the coil into tissue and of the fully engaged endpoint of embedding the coil 54 into the target tissue, by observing thechanging distance between marker 66 and a reference such as the hub 57or other radiopaque marker.

The hub 57 comprises a proximal connector for engagement with arotational driver as discussed elsewhere herein. In one implementation,the connector comprises an aperture such as a hexagonal aperture forremovably engaging a complementary surface structure on the distal endof the driver. A suture 74 is secured to the anchor assembly 50, forexample secured to the hub 57, coil 54 or core wire 62. In theillustrated embodiment, the suture 74 is attached to a cross pin 76which may be inserted through one or two apertures in the sidewall ofthe hub and across a central hub lumen. The suture may additionallycarry one or two or more radiopaque markers 82 spaced apart from the hub57, and may extend proximally through the proximal connector and acentral lumen in the rotational driver.

A suture lock guide such as a tubular sleeve 78 extends proximally fromthe hub 57 for at least about 2 mm or 4 mm or 8 mm but generally no morethan about 5 cm or 2 cm depending upon desired performance. The guidesleeve 78 may comprise a flexible material such as ePTFE. Preferably aradiopaque marker band 80 is carried by the proximal end of sleeve 78and spaced axially apart from the marker 82 on suture 74, to facilitatefluoroscopic visualization of the suture lock as it is advanced distallyover the suture 74. The marker band 80 may be positioned in between aninner layer and an outer layer of ePTFE sleeve, such as may result fromplacing the band over the sleeve and inverting the sleeve over itself toentrap the ring.

The suture lock guide may comprise any of a variety of structures suchas a sleeve as illustrated or an alignment pin extending proximally fromthe hub and received within a lumen in the suture lock, for maintainingthe orientation of the suture lock following detachment from thedeployment catheter. Since the tension on the suture is optimized whilethe suture lock is held in place by the deployment catheter, any changein the orientation of the suture lock following release from thecatheter would affect tension on the leaflet and potentially negativelyaffect the therapeutic value of the implant. The suture lock guide helpsmaintain constant the maximum distance between the ventricular anchorand the leaflet anchor both pre and post deployment from the catheter.In this manner the maximum tension on the leaflet suture (duringsystole) remains unchanged after the suture lock has been locked, bothbefore and after detachment of the catheter.

The helical anchor assembly 50 may be delivered by a ventricular anchordelivery subsystem 300. FIGS. 2C-2E illustrate various views of aventricular anchor delivery subsystem 300 and its components. FIG. 2Cdepicts a perspective view of a distal end of the subsystem 300. FIG. 2Ddepicts a perspective view of a proximal end of the subsystem 300. FIG.2E depicts a partially exploded view of a distal end of the subsystem300.

The subsystem 300 may be delivered through the delivery catheter 100.The delivery catheter 100 may access the left atrium throughconventional techniques, such as through an atrial trans-septalpuncture. The delivery catheter 100 may be maintained in a substantiallyconstant location throughout the procedure as various subsystems areplaced and removed from the delivery catheter 100. For instance, thedistal end of the delivery catheter 100 may be positioned in the leftatrium. In other implementations, the distal end of the deliverycatheter 100 may be positioned in the left ventricle throughout theduration of the procedure.

As shown in FIGS. 2C-2E, the ventricular anchor delivery subsystem 300may comprise an outer sheath 304, a driver (comprising shaft 307 andhead 306), an anchor hub 308, and an anchor 302. The anchor may be ahelical anchor 302 and the drive head 306 can be configured to rotatethe helical anchor 302. The helical anchor 302 may comprise an innerdiameter configured to be received over the outer diameter of an anchorhub 308. The helical anchor 302 may be securely fixed secured to theanchor hub 308 by an interference fit or other frictional engagement,soldering or other known attachment technique. The anchor hub 308 may beleft implanted along with the helical anchor 302.

The anchor hub 308 may comprise a lumen positioned substantially along acentral axis of the anchor hub 308 for receiving a suture 74 (FIG. 2A)and attaching the suture 74 to the helical anchor 302. In someembodiments, the suture 74 may comprise an attachment element (e.g. aknot or a washer) with a diameter sized to prevent the suture 74 frombeing pulled proximally through the anchor hub 308 lumen. For example,the suture 74 may be knotted on a distal side of the lumen. In someembodiments, the suture 74 may be tied to the anchor hub 308 (e.g.,passed through the lumen, wrapped around a structure such as the outersurface or a cross pin 76 as shown in FIG. 2B, and tied to itself).

The helical anchor 302 may comprise a distal section of windings and aproximal section of windings. The proximal section of windings may bespaced closer together than the distal section of windings and may beconfigured for securing the helical anchor 302 to the anchor hub 308.The distal section of windings may be spaced further apart than theproximal section of windings and may be configured for insertion intothe ventricular tissue. The anchor hub 308 may comprise an enlargedcross-section at its proximal end configured to abut the helical anchor302 and/or prevent the helical anchor 302 from advancing proximally overthe proximal end of the anchor hub 308. Other helical anchors, such asthose described elsewhere herein, may be configured to be used with theventricular anchor delivery subsystem 300 described herein as well.

The proximal face of the helical anchor 308 may comprise a recess forreceiving an extending portion 306′ of the driver head 306. The recessmay be non-circular (e.g., oblong or polygonal such as hexagonal) suchthat it is configured to transfer torque from the driver to the anchorhub 308 upon rotation of the driver. The recess may be positioned aroundthe central lumen of the anchor hub 308.

In other embodiments, the anchor hub 308 may comprise an extendingportion and the driver 306 may have a complementary recess. The driverhead 306 may be generally cylindrical, with a distally facing post oraperture with a complementary configuration to rotationally engage thecorresponding component on the anchor. The driver head 306 may befixedly coupled to a drive shaft 307. The driver may comprise a centrallumen through the driver head 306 and drive shaft 307 configured toreceive the suture 74. The central lumen of the driver may be configuredto be aligned with the central lumen of the anchor hub 308. The driveshaft 307 may be received within a guide shaft 305. The diameter of thedriver head 306 may be larger than the inner diameter of the guide shaft305. The outer sheath 304 may be sized to receive the guide shaft 305 aswell as the driver head 306, the anchor hub 308, and the helical anchor302.

The outer sheath 304 may be delivered into the left ventricle andproximal to the ventricular attachment site via the delivery catheter100. In some embodiments, the outer sheath 304 may be delivered withouta delivery catheter. In some implementations, the helical anchor 302 maybe concealed within the outer sheath 304 until the outer sheath 304 ispositioned proximal to the ventricular attachment site then pusheddistally through the outer sheath 304 or the outer sheath 304 isproximally retracted so that the helical anchor 302 is exposed. Thehelical anchor 302 may be placed into contact with the ventriculartissue. Rotation of the drive shaft 307 may cause the driver head 306,the anchor hub 308, and the helical anchor 302 to rotate therebyscrewing the ventricular anchor 302 into the ventricular tissue.Rotation of the driver 309 may axially advance the driver 309, anchorhub 308, and helical screw 302 in a distal direction with respect to theouter sheath 304.

The drive shaft 307 may be rotated manually by a user using a drivehandle 312, as shown in FIG. 2D. The proximal end of the ventricularanchor delivery subsystem 300, as illustrated in FIG. 2D, may comprisefirst and second hemostasis valves 314, 316. The first hemostasis valve314 may be positioned distal to the drive handle 312 and may provideaccess to the guide shaft 305. The second hemostasis valve 316 may bepositioned proximal to the drive handle 312 and may provide access tothe central lumen of the driver. The ventricular anchor suture (notshown) may extend through the second hemostasis valve 316.

In some implementations, the inserting portion 306′ of the driver head306 and the recess of the anchor hub 308 may have a frictionalengagement that transiently holds the two components together. Thefrictional engagement may be overcome upon proximal retraction of thedriver by a counter force from the ventricular tissue once the helicalanchor 302 is inserted. In some implementations, proximal tension on thesuture 74 may provide an engagement force between the proximal hub 308and the driver head 306, which can be released upon retraction of thedriver 309. The driver head 306 may be proximally withdrawn into theouter sheath 304 before the outer sheath 304 is withdrawn into thedelivery catheter 100.

The non-implanted components of the ventricular anchor deliverysubsystem 300 may be removed from the delivery catheter 100 andsubsequent subsystems may be placed in the delivery catheter 100 forcompleting implantation of the neo chordae. In a modified embodiment,the ventricular anchor delivery subsystem 300 and subsequent subsystemssuch as the leaflet anchor delivery subsystem 330 may be positionedwithin the delivery catheter 100 at the same time and in certainarrangements the tissue and leaflet anchors can both be preloaded intothe delivery catheter. In alternative embodiments, the implantation ofthe ventricular anchor may be performed in a different order (e.g.,after the implantation of the leaflet anchor). The ventricular anchordelivery components may be proximally retracted over a proximal end ofthe suture 74, which may remain extending through the delivery catheter100 to the ventricular anchor 302.

FIGS. 3-6 depict the deployment of the leaflet anchor. Referring to FIG.3, the ventricular anchor 32 has been deployed and is tethered to thecatheter 100 by a ventricular anchor suture 74 and the ventricularanchor subsystem has been removed. The leaflet anchor is carried withina needle 338, shown aimed at a target site on the atrial side of theleaflet. The needle 338 is axially reciprocally carried within thecatheter 100, such as within a tubular sleeve 332 advanceable throughthe catheter 100. Additional details of the needle and needle driver arediscussed below.

As shown in FIG. 3, in the illustrated arrangement, the needle can crossthrough the leaflet from the atrium to the ventricle and a preloadedsuture can then be advanced into the ventricle. The suture can then beused to collapse the pledget against the ventricular side of the leafletto anchor the suture to the leaflet as shown in FIG. 4. Thus the pledgetforms a radially enlargeable leaflet anchor. In certain embodiments,other forms of a radially enlargeable leaflet anchor can be used.

The leaflet anchor and suture can then be used in combination with aventricular anchor, suture and suture lock to effectively create a newmitral chord as shown in FIG. 5. As noted above, the leaflet anchor andsuture can be used in combination with the systems and methods for thetransvascular prosthetic chordae tendinae implantation disclosed in theU.S. patent application Ser. No. 15/858,671 (the entirety of which isincorporated by reference herein) and the various embodiments ofventricular anchors, sutures and suture locks disclosed therein.

Preferably, the leaflet anchor deployment subassembly is provided with atemporary anchor for capturing and stabilizing the leaflet while theneedle tip 338 is advanced therethrough at a target side. As illustratedin FIG. 3 and FIG. 4, a distal end 400 of delivery tube 332 or othersystem component carries a temporary tissue anchor such as a helicaltissue anchor 402. Anchor 402 may be similar to ventricular anchor 54except that temporary anchor 402 does not have a distal barb since it isintended to be only momentarily in engagement with the leaflet. Theanchor 402 thus comprises a helical element 406 which terminates in adistal tip 408.

In use, the distal tip 408 is positioned at a target site on the surfaceof the leaflet, and the helical element 406 is rotated about its axis toengage and penetrate the leaflet. The needle tip 338 may be optionallyengaged with the leaflet prior to rotation of the helical element 406,and utilized to stabilize the anchor against moving away from the targetsite in response to rotation, in a manner similar to that discussed inconnection with the ventricular anchor and FIGS. 2A and 2B.

Following engagement of the helical element 406 to capture the leafletfrom the atrial side and secure the leaflet to the catheter, the needlemay be advanced distally through the central lumen defined by thehelical element 406 and completely through the leaflet so that theneedle tip 338 exits the ventricular side of the leaflet as seen in FIG.4. An anchor deployment actuator such as a pusher extending through theneedle may be utilized to deploy the anchor from the needle and into theventricle.

Referring to FIG. 5, the leaflet anchor may be a pledget 340 similar tothose described elsewhere herein. The pledget 340 may be coupled orattached to the distal end of a leaflet anchor suture 344. The pledgetmay comprise a soft and/or flexible material such as a fabric. Thesuture 344 may extend through the needle 336. The pledget 340 may befolded or compressed in a conformation comprising a reduced radial crosssection such that it may be disposed within the needle 336 for delivery,as shown in FIGS. 8 and 10 discussed below. The pledget 340 may expandfrom a reduced cross section to assume a larger radial cross sectionupon deployment from the distal end of the needle tip 338, as shown inFIG. 5. In some embodiments, the pledget 340 may be pushed through theneedle 336 via a push wire or release wire (not shown). Upon deliverythrough the needle tip 338, proximal retraction of the leaflet suture344 as shown in FIG. 6 may cause the leaflet anchor to assume an axiallycollapsed, radially enlarged conformation which prevents the leafletanchor from being retracted through the puncture in the leaflet andthereby anchors the leaflet suture 344 to the leaflet, as shown in FIG.7.

FIGS. 6A-6D schematically depict a pledget 340 connected to the distalend of a leaflet suture 344. The pledget 340 may comprise two wings 341,342, which may be rolled/folded (e.g., both in a clockwise orcounterclockwise direction) around a longitudinal axis of the pledget340 to form a reduced cross section conformation. In some embodiments,the leaflet suture 344 may be integrally formed with the pledget 340. Inorder to produce a foldable or collapsible configuration, the suture 344may extend distally through the pledget, loop around the distal end ofthe pledget and return proximally and threaded back through one or moreapertures (e.g., two apertures, three apertures, four apertures, etc.)formed in the pledget 340, as shown in FIG. 6A. In some embodiments, theapertures may be aligned along a center of the pledget 340.

The apertures may extend through the pledget 340 and through the portionof the embedded portion of the suture 344 which is integral with thepledget 340. The embedded portion of the suture 344 may be at leastpartially flatted within the pledget 340. In some embodiments, theapertures may be placed substantially near the center of the pledget(e.g., immediately to the left or right of the embedded suture 344 oralternating between the left and right side of the suture 344). Whendeployed the suture 344 may be effectively joined to a distal end of thepledget 340 (e.g., the suture 344 may loop back to where it insertsbetween the pledget sheets).

FIGS. 6B-6D schematically depict an example of a pledget as describedelsewhere herein. FIG. 6B schematically depicts a pledget 340 formed byaffixing a distal end (shown in dashed lines) of the suture 344 betweentwo flat sheets, such that the sheets for left and right wings 341, 342.FIG. 6C shows a cross-section of the pledget 340 along the axis of B-Billustrated in FIG. 6B. In some embodiments, the suture 344 may beinserted between two sheets (e.g., substantially down the middle of thesheets) and pressed and/or laminated to join the three componentstogether (e.g., under heat and/or pressure). At least one of the layersmay be partially sintered. The suture 344 may be flattened and/ordensified to improve resistance to suture tear out. The sheets may beflat polytetrafluoroethylene (PTFE) sheets (e.g., thin uncured expandedPTFE (ePTFE) sheets) or any other suitable material. In someimplementations, the leaflet suture 344 may be disposed between thesheets in alternative configurations, such as a zig-zag or s-shapedconfiguration. FIG. 6D shows the pledget 340 of FIG. 6B comprising aplurality of apertures 343 through which the proximal tail end of thesuture 344 may be threaded through.

In some embodiments, one or more apertures 343 may be formed through thepledget, in various configurations, to form a collapsible structure, asdescribed elsewhere herein, which is configured to anchor the suture 344against the mitral leaflet. FIG. 6D shows apertures 343 alternatingaround opposing sides of the suture 344. In some embodiments, theapertures 343 may be formed on the same side of the suture 344 (e.g., inwing 341 or wing 342). In some embodiments, the apertures 343 may beformed through the suture 344. The apertures 343 may be aligned along acenter of the pledget 340. The apertures 343 may be aligned along thelength of the suture 344 (e.g., may form a straight line). The suture344 may be at least partially flattened between the two opposing sheets,which may facilitate the placement of apertures 343 through the suture344. Various combinations of apertures 343, including the positioningdescribed above, may be used.

The pledget 340 may be formed such that the wings 341, 342 areapproximately the same size or they may be formed to be different sizes.Upon proximal retraction of the leaflet suture 344, the pledget 340 maybe folded to assume an accordion-like conformation, as depicted in FIG.6A. The pledget 340 may assume a conformation comprising a substantiallyplanar proximal surface which is approximately perpendicular to thelongitudinal axis of the leaflet suture 344. This conformation mayfacilitate anchoring the suture 344 in the leaflet. Upon anchoring theleaflet suture 344 in the leaflet, the leaflet anchor delivery subsystem340 may be withdrawn from the delivery catheter 100. The leaflet anchordelivery components may be proximally retracted over a proximal end ofthe suture 344, which may remain extending through the delivery catheter100 to the leaflet anchor 340, alongside the ventricular anchor suture74.

FIGS. 8-10 illustrate various views of the leaflet anchor deliverysubsystem 330 and its components. FIG. 8 depicts a perspective view of adistal end of the subsystem 330. FIG. 9 depicts a perspective view of aproximal end of the subsystem 330. FIG. 10 depicts an exploded view ofthe distal end of the subsystem 330.

As shown in FIGS. 8 and 10, the leaflet anchor delivery subsystem 330may comprise an outer delivery tube 332. The tube 332 may optionallyinclude a deflection zone and may be configured to be steerable by anoperator such as by proximal retraction of one or two or more pull wires(not shown) along various sides of the flex tube 332. The operator maycontrol the flexion of the flex tube via a knob 352 or lever or otheractuation mechanism positioned on a handle 350 at the proximal end ofthe leaflet anchor delivery subsystem 330, as shown in FIG. 9.

An internal tubular shaft or needle 336 terminating at a distal end witha needle point 338 may extend through the delivery tube 332. Theinternal needle 336 may comprise a hypotube, extrusion or braided tubeor catheter which is flexible enough to conform to the shape of theoptional flex tube 332. A needle tip 338 may be coupled to the distalend of the internal flexible shaft 336. A flexible jacket 333 maysurround the flex tube 332 and a delivery shaft 334.

The proximal end of the internal tubular shaft 336 may be connected to aneedle handle 354, as shown in FIG. 9. The needle handle 354 maycomprise a hemostasis valve 356. The leaflet suture 344 may be insertedthrough valve 356. Valve 356 may be a tuohy-borst valve. The needlehandle 354 may include additional ports 358 for accessing the lumen ofthe internal flexible shaft 336. The needle handle 354 may be positionedproximally to the handle 350 such that the internal flexible shaft 336extends through the handle 350 and into the lumen of the delivery shaft334. The handle 350 may comprise a hemostasis valve for receiving theinternal flexible shaft 336 and sealing the internal components of thehandle, including the opening to the delivery shaft 334, from theambient environment.

The needle tip 338 may be extendable and retractable by extending theneedle handle 354 toward the handle 350 or retracting the needle handle354 from the handle 350, respectively. Distal advance of the needle 336may be accomplished by manually advancing the handle 354. Alternatively,the distal advance of the needle may be assisted by a mechanical orelectromechanical mechanism to produce a relatively high velocity, lowstroke length distal advance.

Exertion of pressure on the leaflet when the needle tip 338 is extendeddistally beyond the tube 332 may cause the needle tip 338 to puncturethe leaflet such that the needle tip 338 may extend through to theopposite side (e.g., the atrial side) of the leaflet, as shown in FIG.4. This pressure may be exerted by extending the needle tip 338 and/orretracting the entire delivery device 330 in a proximal direction withthe needle tip 338 in an extended position.

The ventricular anchor suture 74 and the leaflet anchor suture 344 maybe coupled together in a tensioned fashion to form the neo chordaeimplant or to join two sections of the neo chordae implant together,such that the neo chordae extends between the ventricular anchor 302 andthe leaflet anchor 340 across the atrial side of the coaptive edge ofthe leaflet. The overall length of the neo chordae may be adjusted byproximal traction of one or both sutures 74, 344 prior to engaging thesuture lock 376 such that an appropriate tension is applied to theleaflet, with the tension subsequently maintained by the ventricularanchor 302. The sutures 74, 344 may remain extending proximally throughthe delivery catheter 100 to a location outside the body. In someembodiments, the proximal ends of the suture 74, 344 may be fed into ahandle or proximal portion of a suture lock delivery system 370 tofacilitate placement of the suture lock and cutting of the sutures 74,344. In some embodiments, the proximal ends may remain free or coupledor secured by other means.

FIG. 11 depicts the advancement of suture lock 376 over the ventricularanchor suture 74 and the leaflet suture 344. The suture lock deliverysubsystem 370 may be advanced through the delivery catheter 100 and atubular pusher catheter 372 may push a suture lock 376 along the distaldirection of the sutures 74, 344. Once the suture lock 376 has reachedthe ventricle, it can continue to be pushed along the ventricle suture74 with proximal traction on the suture 74 and while allowing theleaflet suture 344 to feed distally through the catheter if needed forthe suture lock 376 to advance distally to the ventricular anchor. Asdiscussed further below, FIG. 12 illustrates the final construct withthe leaflet anchor and ventricular anchors tethered together to form anartificial chordae. The proximal tails of the two sutures has beensevered and catheter proximally retracted from the ventricle through themitral valve.

FIGS. 13-14 illustrate various views of the suture lock deliverysubsystem 370 and its components. FIG. 13 depicts a perspective view ofa distal end of the subsystem 370. FIG. 14 depicts a perspective view ofa proximal end of the subsystem 370. FIG. 15 depicts a partiallyexploded view of the distal end of the subsystem 370. FIG. 16 depicts aperspective view of a distal end of a cutting assembly. FIGS. 17 and 18depict side views of a cutting assembly portion of the subsystem 370.FIG. 19 depicts a side view of a suture lock 376 and a distal end of atorque driver 388 configured to engage the suture lock 376. FIGS. 20 and21 depict a proximal end view and a distal end view, respectively, ofthe suture lock 376.

The suture lock delivery subsystem 370 may be configured to advance(e.g., slide) a suture lock 376 over both the sutures 74, 344 (or eventhree or four or additional sutures) securing them together. The sutures74, 344 may each be proximally retracted relative to the suture lock 376to tension the sutures 74, 344 and modulate the length of each suture74, 344 between the suture lock 376 and the respective tissue anchors302, 340. Once the tension and length of the neo chordae implant isoptimized, the suture lock 376 may be locked to fix the length of thesutures 74, 344 such that the sutures 74, 344 can no longer move withrespect to the suture lock 376. The sutures 74, 344 may then be severedat a point proximal to the suture lock 376. The suture 74, 344 may becut by the same suture lock delivery subsystem 370 which delivered thesuture lock 376. In other embodiments, a separate cutting device may beinserted into the delivery catheter 100 after the suture lock has beenlocked in place.

The suture lock allows one or two or more sutures to be advancedtherethrough and adjusted, and then locked with sufficient clampingefficiency that an ePTFE suture can be prevented from slipping from thesuture lock under normal use conditions (e.g., withstand tension of atleast about 60% or 80% or more of the suture breaking strength, withoutslipping). The lock may be reopened to permit readjustment of thetension on the mitral leaflet, and retightened, until a desired resulthas been achieved. The tightening tool may then be removed, leaving thesuture lock behind.

The suture lock 376 may be advanced along the sutures by a retainercatheter 373. The distal end of the retainer catheter 373 may be coupledto a retainer element 377 (FIG. 15). The retainer element may comprise aflange 371 or other mechanical feature configured to engage the suturelock 376. For example, the flange 371 may be inserted into a recess at aproximal end of the suture lock 376. In some embodiments, rotation ofthe retainer catheter 373 and/or translation substantially perpendicularto the axial direction of the retainer catheter 373 may be used todisengage the retainer catheter 373 from the suture lock 376.

The sutures 74, 344 may extend from their respective tissue anchors topass through the suture lock 376, entering from a distal opening 395 ina distal face of the suture lock 376, shown in FIG. 21, and exiting at aproximal opening 394 to the suture path in a proximal face of the suturelock 376, shown in FIG. 20. The sutures 74, 344 may extend through achannel in a cutter head 375 proximal to the suture lock 376 and alongthe outside of the retainer catheter 373 and through the deliverycatheter 100. The cutter head 375 may be coupled to the distal end of acutter catheter 372. The retainer catheter 373 may extend through aninternal lumen of the cutter catheter 372 such that the two catheters372, 373 may be extendable or retractable relative to one another.

Once the sutures 74, 344 are locked (fixedly secured) within the suturelock 376, the proximal ends of the suture 74, 344 may be cut adjacent tothe proximal face of the suture lock. The sutures 74, 344 may be cut byadvancing the cutter catheter 372 coupled to the cutter head 375 towardthe proximal face of the suture lock 376. As schematically illustratedin FIGS. 17-18, as the cutter head 375 advances along the retainercatheter 373 toward the retainer element 377, the cutter head brings thesutures 74, 344 into close proximity to a cutting blade 379 positionedon the retainer element 377. The cutter head 375 is configured toadvance over the retainer element 377 in such a fashion that the channelin the cutter head 375 retaining the sutures 74, 344 becomesincreasingly spatially occupied by the blade 379. As the blade 379 isforced into the channel of the cutter head 375, the blade 379 shears thesutures 74, 344. Application of proximal tension to the sutures 74, 344may facilitate the cutting of the sutures 74, 344. In other embodiments,different actuations (e.g., rotation of a cutting catheter) can beconfigured to sever the sutures 74, 344.

In some implementations, more than two sutures may be employed and maybe locked within the suture lock 376 and severed by the suture lockdelivery subsystem 370 in the same fashion. In some embodiments,advancement of the cutter head 375 over the retainer element 377 mayfacilitate the disengagement of the retainer catheter 373 from thesuture lock 376. For example, the cutter head 375 may advance to adistal position where it is configured to stabilize the suture lock 376,allowing the retainer catheter 373 to be axially and/or rotationallydisengaged from the suture lock 376.

FIG. 19 illustrates a side view of an example of a suture lock 376(shown with its outer casing/shell removed). The sutures may passthrough the suture lock 376 from a distal end to a proximal end asdescribed elsewhere herein. The suture lock 376 may comprise a screw 382configured to distally advance or proximally retract a push wedge 384,depending on the direction of rotation of the screw. The screw 382 maybe rotated by a torque shaft 388. The torque shaft 388 may comprise adriver head configured to mate with recess 381 (e.g., a polygonal recessor other non-circular shaped recess, as shown in FIG. 20) positioned atthe proximal end of the suture lock 376 such that rotation of the torqueshaft 388 causes rotation of the screw 382. The torque shaft 388 mayextend through an internal lumen of the retainer catheter 373. Thetorque shaft 388 may be rotated at its proximal end by a knob 398 orother actuation mechanism positioned at a proximal end of the subsystemhandle 396. The handle 396 may include a hemostasis valve 397. In someimplementations, the sutures 311, 344 may pass through the hemostasisvalve 397.

Advancement of the push wedge 384 by the torque shaft 388 may cause aramp or angled surface 386 to gradually compress one or more springs,such as spring pins 388. The springs bias the clamp upward to open thesuture path until forced closure by rotation of the torque shaft 388.Compression of the one or more springs 388 may force a clamp 390downward on the sutures 311, 344, compressing the sutures 311, 344between two opposing surfaces. In some embodiments, the clamp 390 andthe opposing surface 392 may have notched surfaces configured to matewith each other at discrete increments. The mated notched surfaces mayprovide enhanced friction and in some implementations mechanicalinterference for retention of the sutures 311, 344 between the opposingsurfaces such that they cannot be withdrawn, either proximally ordistally, from the suture lock 376. In some embodiments, the tighteningmay be reversible by rotating the torque shaft in an opposite direction.

Once the suture lock is properly positioned over the sutures 74, 344 andlocked into place, the sutures 74, 344 may be severed as describedelsewhere herein. FIG. 12 depicts the retraction of the suture lockdelivery subsystem 370 after the sutures 74, 344 have been cut. Once thesuture lock delivery subsystem 370 has been removed from the deliverycatheter 100, the delivery catheter 100 may be withdrawn from the body.

Although this disclosure describes certain embodiments and examples,many aspects of the above-described systems and methods may be combineddifferently and/or modified to form still further embodiments oracceptable examples. All such modifications and variations are intendedto be included herein within the scope of this disclosure. Indeed, awide variety of designs and approaches are possible and are within thescope of this disclosure.

Furthermore, certain features that are described in this disclosure inthe context of separate implementations can also be implemented incombination in a single implementation. Conversely, various featuresthat are described in the context of a single implementation can also beimplemented in multiple implementations separately or in any suitablesubcombination. Moreover, although features may be described above asacting in certain combinations, one or more features from a claimedcombination can, in some cases, be excised from the combination, and thecombination may be claimed as a subcombination or variation of a subcombination.

The disclosure herein of any particular feature, aspect, method,property, characteristic, quality, attribute, element, or the like inconnection with various embodiments can be used in all other embodimentsset forth herein. Also, any methods described herein may be practicedusing any device suitable for performing the recited steps.

Moreover, while components and operations may be depicted in thedrawings or described in the specification in a particular arrangementor order, such components and operations need not be arranged andperformed in the particular arrangement and order shown, nor insequential order, nor include all of the components and operations, toachieve desirable results. Other components and operations that are notdepicted or described can be incorporated in the embodiments andexamples. For example, one or more additional operations can beperformed before, after, simultaneously, or between any of the describedoperations. Further, the operations may be rearranged or reordered inother implementations. Also, the separation of various system componentsin the implementations described above should not be understood asrequiring such separation in all implementations, and it should beunderstood that the described components and systems can generally beintegrated together in a single product or packaged into multipleproducts.

In summary, various illustrative embodiments and examples are describedherein. Although the systems and methods have been disclosed in thecontext of those embodiments and examples, this disclosure extendsbeyond the specifically disclosed embodiments to other alternativeembodiments and/or other uses of the embodiments, as well as to certainmodifications and equivalents thereof. This disclosure expresslycontemplates that various features and aspects of the disclosedembodiments can be combined with, or substituted for, one another.Accordingly, the scope of this disclosure should not be limited by theparticular disclosed embodiments described above, but should bedetermined only by a fair reading of the claims that follow as well astheir full scope of equivalents.

What is claimed is:
 1. A neo chordae tendinae deployment system,comprising: a catheter having a proximal end and a distal end; a helicalventricular anchor subassembly extendable through the catheter, having aventricular suture extending proximally through the catheter; and aleaflet anchor deployment subassembly extendable through the catheter,having a radially enlargeable leaflet anchor within the subassembly andhaving a leaflet suture extending proximally through the catheter. 2.The neo chordae tendinae deployment system as in claim 1, wherein theradially enlargeable leaflet anchor comprises a pledget.
 3. The neochordae tendinae deployment system as in claim 2, wherein the pledget istransformable from an elongate strip configuration to a radiallyenlarged, axially shortened configuration by proximal retraction of thesuture.
 4. The neo chordae tendinae deployment system as in claim 1,wherein the radially enlargeable leaflet anchor comprises the leafletsuture positioned between two sheets of material.
 5. The neo chordaetendinae deployment system as in claim 1 wherein the radiallyenlargeable leaflet anchor is carried within a needle having a sharpenedend for piercing the leaflet.
 6. The neo chordae tendinae deploymentsystem as in claim 5, wherein the leaflet anchor deployment subassemblycomprises an elongate tube having a distal end and a central lumen, anda leaflet connector on the distal end.
 7. The neo chordae tendinaedeployment system as in claim 6, wherein the leaflet connector comprisesa helical leaflet anchor.
 8. The neo chordae tendinae deployment systemas in claim 7, wherein the needle is axially movable with respect to thehelical leaflet anchor.
 9. The neo chordae tendinae deployment system asin claim 1 further comprising a suture locking subassembly, advanceablethrough the catheter and configured to connect the ventricular suture tothe leaflet suture.
 10. The neo chordae tendinae deployment system as inclaim 1, wherein the ventricular anchor subassembly comprises an outertubular sheath having a rotatable anchor driver extending therethroughand a helical ventricular anchor removably carried by the anchor driver.11. The neo chordae tendinae deployment system as in claim 10, furthercomprising a hub between the anchor driver and the helical ventricularanchor.
 12. The neo chordae tendinae deployment system as in claim 10,further comprising a suture lock guide on a proximal end of theventricular anchor.
 13. The neo chordae tendinae deployment system as inclaim 12, wherein the suture lock guide comprises a proximally extendingtubular sleeve configured to receive a suture lock.
 14. The neo chordaetendinae deployment system as in claim 13, further comprising aradiopaque marker carried by the suture lock guide.
 15. The neo chordaetendinae deployment system as in claim 10, further comprising a corewire extending axially through the helical anchor.
 16. The neo chordaetendinae deployment system as in claim 15, further comprising a tissuedepth indicator carried by the core wire.
 17. The neo chordae tendinaedeployment system as in claim 16, further comprising a spring to biasthe depth indicator in the distal direction.
 18. The neo chordaetendinae deployment system as in claim 1, wherein the catheter isdimensioned to simultaneously receive the leaflet anchor deploymentsubassembly and the ventricular suture therethrough.
 19. The neo chordaetendinae deployment system as in claim 18, further comprising a suturelock delivery subassembly.
 20. The neo chordae tendinae deploymentsystem as in claim 19, wherein the suture lock delivery subassembly isconfigured to advance a suture lock simultaneously along the leafletsuture and the ventricular suture.